Stroke Treatment With Acute Reperfusion and Simvastatin

Summary

The purpose of this study is to determine whether simvastatin treatment started within the first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at seventh day/discharge or at the third month. Also, to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis.

Timeline

Start

2009-04

Primary completion

2014-06

Completion

2014-06

Outcome

Missed primary endpoint

paper No differences were found between treatment arms regarding the primary outcome (adjusted odds ratio, 0.99 [0.35-2.78]; P=0.98). PMID 27758944 ↗

Publications

• Montaner J, Bustamante A, Garcia-Matas S, Martinez-Zabaleta M, Jimenez C, de la Torre J, Rubio FR, Segura T, Masjuan J, Canovas D, Freijo M, Delgado-Mederos R, Tejada J, Lago A, Bravo Y, Corbeto N, Giralt D, Vives-Pastor B, de Arce A, Moniche F, Delgado P, Ribo M; STARS Investigators. Combination of Thrombolysis and Statins in Acute Stroke Is Safe: Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin). Stroke. 2016 Nov;47(11):2870-2873. doi: 10.1161/STROKEAHA.116.014600. Epub 2016 Oct 6.

Drugs

Indications